Efficacy of a Mindfulness-Based Stress Management Program for Allogeneic HCT Caregivers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Burden
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 505
- Locations
- 1
- Primary Endpoint
- Patient Distress at 6 Month Follow-up (CESD)
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
Brief Summary
The purpose of the study is to understand whether different stress management interventions impact stress among HCT cancer caregivers and patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Caregiver Inclusion Criteria:
- •Caring for a patient planning to receive an allogeneic HCT at Moffitt
- •Intending to remain primary caregiver throughout patient treatment (i.e., will be the caregiver the majority of the time)
- •Able to provide informed consent
- •Able to read and write in English
- •Owns a smartphone and is willing to download the study app
- •Patient Inclusion Criteria:
- •Receiving an allogeneic HCT at the cancer center
- •Able to provide informed consent
- •Able to read and write in English
Exclusion Criteria
- •Under 21 years of age
- •Unable to provide informed consent
- •Unable to read and write in English
- •Caregiver is unable to remain primary caregiver throughout patient treatment
- •Patient does not receive transplant at Moffitt Cancer Center
Outcomes
Primary Outcomes
Patient Distress at 6 Month Follow-up (CESD)
Time Frame: 6 Month Follow-up after end of treatment
Patient distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD). The CESD is comprised of 20 4-point Likert scale items and has been commonly used among cancer caregivers. Participants rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Patient Distress at 6 Month Follow-up (GAD-7)
Time Frame: 6 Month Follow-up after end of treatment
Patient distress will be measured using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is comprised of 8 items on a 4-point Likert scale and has been used extensively among cancer caregivers. Participants rate the severity of his or her symptoms over the past two weeks. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions
Caregiver Burden at 2 Month Follow-up
Time Frame: 2 month follow up after end of treatment
Caregiver burden will be measured using the Zarit Burden Interview Short Form (ZBI). The ZBI is 12 items using a 5-point Likert scale assessing caregiver burden. Participants rate burden on a scale of 0 to 4, 0 indicating "rarely" an issue and 4 indicating "nearly always". The ZBI has been validated in populations of cancer caregivers and has demonstrated very good internal consistency and discriminative ability
Patient Distress at 2 Month Follow-up (CESD)
Time Frame: 2 Month Follow-up after end of treatment
Patient distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD). The CESD is comprised of 20 4-point Likert scale items and has been commonly used among cancer caregivers. Participants rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Caregiver Burden at End of Treatment
Time Frame: Up to 8 Weeks
Caregiver burden will be measured using the Zarit Burden Interview Short Form (ZBI). The ZBI is 12 items using a 5-point Likert scale assessing caregiver burden. Participants rate burden on a scale of 0 to 4, 0 indicating "rarely" an issue and 4 indicating "nearly always" The ZBI has been validated in populations of cancer caregivers and has demonstrated very good internal consistency and discriminative ability
Caregiver Burden at 6 Month Follow-up
Time Frame: 6 month follow up after end of treatment
Caregiver burden will be measured using the Zarit Burden Interview Short Form (ZBI). The ZBI is 12 items using a 5-point Likert scale assessing caregiver burden. Participants rate burden on a scale of 0 to 4, 0 indicating "rarely" an issue and 4 indicating "nearly always". The ZBI has been validated in populations of cancer caregivers and has demonstrated very good internal consistency and discriminative ability
Patient Distress at End of Treatment (CESD)
Time Frame: Up to 8 Weeks
Patient distress will be measured using the Center for Epidemiological Studies Depression Scale (CESD). The CESD is comprised of 20 4-point Likert scale items and has been commonly used among cancer caregivers. Participants rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Patient Distress at End of Treatment (GAD-7)
Time Frame: Up to 8 Weeks
Patient distress will be measured using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is comprised of 8 items on a 4-point Likert scale and has been used extensively among cancer caregivers. Participants rate the severity of his or her symptoms over the past two weeks. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions
Patient Distress at 2 Month Follow-up (GAD-7)
Time Frame: 2 Month Follow-up after end of treatment
Patient distress will be measured using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is comprised of 8 items on a 4-point Likert scale and has been used extensively among cancer caregivers. Participants rate the severity of his or her symptoms over the past two weeks. The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions
Secondary Outcomes
- Patient Healthcare Utilization - unexpected clinic visits post discharge at 6 Month Follow-up(6 Month Follow-up after end of treatment)
- Patient Healthcare Utilization - Readmissions to the hospital at 6 Month Follow-up(6 Month Follow-up after end of treatment)